Monday, August 29, 2011

The Endocrine Society calls for the Enhanced Use of Accredited Centralized Institutional Review Boards to Facilitate Research

Recently, the Endocrine Society published a position statement advocating the expanded use of centralized institutional review boards in order to facilitate clinical research. The Endocrine Society, considering research participant safety a key priority, supported the position that central institutional boards be accredited, and mentioned the Association for the Accreditation of Human Research Protection Programs. In an August 2, 2011 press release the president of the Endocrine society, Janet E. Hall, M.D., stated that “The number of approvals necessary to proceed with a multi-site study that utilizes each site’s IRB may involve waiting periods of a year or more. This process delays the progress of the study, discourages the investigators involved and is highly cost-ineffective. The Endocrine Society strongly encourages the utilization of CIRBs for multicenter clinical studies in order to advance clinical research and improve patient care while maintaining the highest patient safety standards.”

It has long been argued that multiple reviews by each organization’s IRB is time consuming, a waste of resources, and adds little, or even subtracts from, the protection of participants in research. In order to address these concerns, the advanced notice of proposed rulemaking concerning revisions of the regulating governing human participant research, which was released by the Department of Health and Human Services on July 26, 2011, proposed the utilization of a single IRB review of record for domestic sites of multi-site projects.

If a single IRB is used as an IRB of record for multi-site projects, an IRB from an accredited organization would be the optimum choice for review. Accredited organizations meet the high standards of human research protection. Recognizing those standards, when a research protocol is reviewed at an accredited organization, one is more likely to trust and rely on that review. “Striving to exceed the federal requirements and continually seeking new safeguards for protecting research participants, accreditation is an ongoing process that ensures the public, government officials, and research participants that clinical trials are both ethical and of high quality,” said Marjorie A. Speers, Ph.D., President and CEO, AAHRPP.

Accreditation is facilitating collaborative relationships and reliance among organizations and IRBs, resulting in more efficient process that maintains high standards in human research protections.

To read the entire position statement, click here.

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